TEST:

DetermaIO™

"Oncocyte Corp...announced that Chief Executive Officer Josh Riggs and Chief Financial Officer Andrea James will attend “J.P. Morgan Week,” coinciding with the 43ʳᵈ Annual J.P. Morgan Healthcare Conference in San Francisco, from January 13-16, 2025."

We performed a comprehensive evaluation of liver-metastatic (LM) disease among mCRC patients enrolled in the phase II randomized AtezoTRIBE trial, that showed a modest benefit from the addition of atezolizumab (atezo) to 1st line FOLFOXIRI/bevacizumab (bev) and identified Immunoscore IC as a predictor of ICI efficacy in the proficient mismatch repair (pMMR) population... In our cohort of pMMR mCRC patients, the immune microenvironment of tumors with LM spread does not differ from that of tumors with no liver involvement. The presence or not of LM disease does not affect the efficacy of adding atezo to first-line FOLFOXIRI/bev, differently than Immunoscore IC.

This dataset reaffirms excellent outcomes for T1c, chemo-treated TNBC, and highlights a potential role for chemo-deescalated, ICI-based therapy for patients with IO+ and sTIL-lo/int tumors who are predicted to benefit from ICI but who still are at high risk of recurrence without systemic therapy. A clinical trial is warranted to evaluate efficacy of ICI in T1c TNBC, and to test the utility of IO score for determining ICI benefit in this setting.

"Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO™."

P3 | N=278 | NeoTRIPaPDL1 (NCT02620280) | "Oncocyte Corp...announced the peer-reviewed publication of positive data related to its proprietary gene expression test, DetermaIO....As noted above, patients receiving a DetermaIO-positive (IO+) result had a significantly higher pathologic complete response (pCR) rate when treated with atezolizumab plus chemotherapy (69.8%) compared to chemotherapy alone (46.9%). DetermaIO-negative (IO-) result patients did not show improved pCR rates with the addition of atezolizumab compared to chemotherapy alone (44.6% vs 49.2%). The interaction test between DetermaIO and the treatment arm was statistically significant (P-value = 0.043). In an unselected patient population, the addition of atezolizumab achieved a numerically higher pCR rate (48.6%) but did not show a significant improvement over the chemotherapy-only arm (44.4%) in patients with TNBC."

We assessed the 27-gene RT-qPCR-based DetermaIO assay and the same score calculated from RNA sequencing (RNA-seq) data as predictors of sensitivity to immune checkpoint therapy in the neoTRIPaPDL1 randomized trial that compared neoadjuvant carboplatin/nab-paclitaxel chemotherapy (CT) plus atezolizumab with CT alone in stage II/III triple-negative breast cancer. We also assessed the predictive function of the immuno-oncology (IO) score in expression data of patients treated with pembrolizumab plus paclitaxel (N = 29) or CT alone (N = 56) in the I-SPY2 trial...In IO-negative cancers, pCR rates were 46.7% versus 16.1%. DetermaIO identified patients who benefited from neoadjuvant immunotherapy resulting in improved pCR rate, independently of PDL1.

We performed a comprehensive evaluation of LM among mCRC patients enrolled in the phase II randomized AtezoTRIBE trial, that showed a modest benefit from the addition of atezolizumab (atezo) to 1-line FOLFOXIRI/bevacizumab (bev) and identified Immunoscore IC as a predictor of ICI efficacy in the proficient mismatch repair (pMMR) population. We investigated the association of LM disease with tumor immune-related biomarkers – including MMR, TMB, Immunoscore IC, Immunoscore, Tumor-Infiltrating lymphocytes (TILs) assessed by optical microscope, PD-L1 expression by Tumor Proportion Score (TPS), and the immune 27-gene signature DetermaIO – and treatment outcome, in the cohort of patients with pMMR tumor enrolled in the AtezoTRIBE study. 151 (75%) out of 202 enrolled patients with pMMR tumor had LM... In our cohort of pMMR mCRC patients, the immune microenvironment of tumors with LM spread does not differ from that of tumors with no liver involvement. The presence or not of LM does not affect the efficacy of adding atezo to first-line FOLFOXIRI/bev, differently than Immunoscore IC.

Investor Presentation

P2; These results provide data on an alternative anthracycline-free chemoimmunotherapy regimen for patients who are not eligible for anthracycline-based regimens and support further evaluation of this regimen as a chemotherapy de-escalation strategy in randomized studies for TNBC. ClinicalTrials.gov Identifier: NCT03639948.

Subjects with stage II-III TNBC were randomized 1:1 (n=12) to receive induction pembrolizumab (200mg IV) +/- peri-areolar IRX-2 (IRX-2 arm: 1 ml SQ x2 daily for 10 days + cyclophosphamide 300 mg/m2 IV x 1) preceding initiation of pembrolizumab + NAC... A subset of TNBCs experience brisk IO response following single-cycle IO (IOpath response), which is associated with 100% pCR in this preliminary dataset, highlighting IOpath as a potential surrogate biomarker to guide NAC de-escalation or omission in early-stage TNBC. Baseline 27-gene IO score predicts pCR and week 3 IOpath response. A future study is planned (neoINBRX) to evaluate the feasibility of combining baseline IO score with week 3 IOpath response to identify and treat IO-sensitive tumors with chemotherapy-sparing IO combination therapy.

Further exploration of the IO score and spatial TIL biomarkers is warranted. The clinical trial registration is NCT02734290.

Investor Presentation